The present invention relates to a system and method for bypassing an anastomosis site in a hollow organ, such as, for example, a colon. Embodiments of the present invention relate to systems which include an intra-luminal sheath for bypassing an anastomosis site and an external element which serves to limit movement of the intra-luminal sheath within the hollow organ such that a portion of the intra-luminal sheath resides upstream of the anastomosis site.
Surgical intervention can require an operative union of resected tissues or a bypass of non-resected diseased tissue. Such union procedures, which are termed anastomosis, can be performed via open or minimal invasive surgery where the ligated ends are manually sutured or stapled using a surgical stapler. While an anastomosis may be end-to-end, it could also be performed side-to-side or end-to-side depending on the required reconstruction or bypass. Anastomosis can be performed on vascular structures, the gastrointestinal (GI) tract (including esophagus, stomach, small bowel, large bowel, bile ducts, and pancreas), and the urinary tract (including ureters, urinary bladder and urethra).
An anastomosis is a common procedure, in particular in the gastrointestinal (GI) tract. Virtually all elective resections of gastrointestinal organs are followed by anastomoses to restore continuity; pancreaticoduodenectomy is considered a massive operation, in part, because it requires three separate anastomoses (stomach, biliary tract and pancreas to small bowel). The widespread use of mechanical suturing devices (linear and circular staplers) radically altered gastrointestinal surgery in the last decade.
Although commonly performed, GI anastomosis carry a relatively high risk of anastomotic leaks especially in subjects that are immuno-compromised, such as subjects undergoing chemotherapy. Such leaks must be identified in a reasonable amount of time to allow for medical intervention.
In order to address the problem of anastomotic leaks, several internal sheaths which bypass the anastomotic site have been devised (see U.S. Pat. Nos. 4,905,693 and 6,068,636 and U.S. Patent Application Publication No. 2007/0118157). Such sheaths are typically anchored above (upstream) the anastomotic site thereby enabling the flow of material to circumvent or bypass the anastomosis site.
Although these solutions appear to be promising, anchoring of the sheath to the intraluminal wall via staples, sutures or stent-like rings has the potential of causing tissue trauma and complications during sheath placement and removal.
While reducing the present invention to practice, the present inventors have devised a bypass system which includes an intra-luminal sheath which is maintained upstream of the anastomosis site via a movement-limiting element positioned outside the anastomosed organ, thereby minimizing tissue trauma during positioning and removal.